Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519831
Status:
TERMINATED
Last Update Posted:
2017-06-09
First Post:
2007-08-21
Brief Title:
Ph II of Vinflunine and Cetuximab in Second Line Treatment of NSCLC
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Study of Vinflunine and Cetuximab in the Second Line Treatment of Stage IIIBIV Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug unavailable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as vinflunine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as cetuximab can block tumor growth in different ways Some find tumor cells and help kill them or carry tumor-killing substances to them Others interfere with the ability of tumor cells to grow and spread Giving vinflunine together with cetuximab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving vinflunine together with cetuximab works as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving vinflunine together with cetuximab works as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Estimate the objective response rate in patients receiving vinflunine and cetuximab as second-line therapy for stage IIIB or IV non-small cell lung cancer
Secondary
Determine the progression-free survival of patients treated with this regimen
Determine the safety of this regimen in these patients
Determine the overall survival of patients treated with this regimen
Determine the duration of overall response in these patients
OUTLINE This is a multicenter study
Patients receive vinflunine IV over 15-20 minutes on day 1 and cetuximab IV over 60-120 minutes on days 1 8 and 15 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients with responding disease may receive additional courses beyond 4 courses at the discretion of the principal investigator
After completion of study therapy patients are followed periodically for 6 months
Primary
Estimate the objective response rate in patients receiving vinflunine and cetuximab as second-line therapy for stage IIIB or IV non-small cell lung cancer
Secondary
Determine the progression-free survival of patients treated with this regimen
Determine the safety of this regimen in these patients
Determine the overall survival of patients treated with this regimen
Determine the duration of overall response in these patients
OUTLINE This is a multicenter study
Patients receive vinflunine IV over 15-20 minutes on day 1 and cetuximab IV over 60-120 minutes on days 1 8 and 15 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients with responding disease may receive additional courses beyond 4 courses at the discretion of the principal investigator
After completion of study therapy patients are followed periodically for 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None